# Replimune, Inc. – FDA 483

Source: https://www.keypedia.com/records/483/replimune-inc/906dfe9c-2823-4d38-b298-98d27eeee036

> FDA 483 for Replimune, Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Replimune, Inc.
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Replimune, Inc. in Framingham, MA was inspected from April 17-24, 2025, resulting in two observations. The inspection found issues with untimely closure of deviation investigations and deficiencies in quality agreements with contracted sites. These conditions indicate potential weaknesses in the firm's quality system and oversight of outsourced activities.

## Related Documents

- [CRL](https://www.keypedia.com/records/crl/replimune-inc/c8feb030-31b4-4147-9625-9b92286e435b)

## Related Officers

- [Sharmila Shrestha](https://www.keypedia.com/people/sharmila-shrestha/0a91aac0-76a5-4105-a23b-e0966f1aec0e)
- [investigator](https://www.keypedia.com/people/wei-wang/943039ac-3917-4d32-9f58-1886c56aecdd)
- [Carla A. Lorenzo](https://www.keypedia.com/people/carla-a-lorenzo/049d09e7-bf75-4af5-8812-b13492cd72e3)
- [Bo Liang](https://www.keypedia.com/people/bo-liang/9902f822-7544-4e11-8cdc-49a99627db13)
- [Guo-Chiuan Hung](https://www.keypedia.com/people/guo-chiuan-hung/5ff55dcf-5a60-4c10-ac0a-0cabec7cec02)

Company: https://www.keypedia.com/companies/replimune-inc/aed2f3d2-d153-4e38-af9b-19febd6fd927

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4